We are an FDA registered Contract Research Organization (CRO). We provide analytical chemistry testing, formulation, and assistance with CMC product development in preparation of clinical studies and for final registration/submission needs. Our area of expertise is in providing quality services for the pharmaceutical, biotech, medical device, and dietary supplement industries.
We are very experienced and knowledgeable in analytical method development/validation and product development for drugs and dietary supplements under cGMP environments, particularly working with FDA for submissions and inspections. We have built a high quality standard cGMP lab. We have strong backgrounds in technical, compliance, cGMP quality, managerial, and project management areas.
- Providing services beyond a basic chemistry testing lab for drug product development
- Providing high standard quality services with technically sound data generated and results clearly reported
- Delivering results in a timely and reliable manner to meet the mutually agreed upon client’s needs
- Having a technically strong, focused and dedicated support team
- Offering favorable price structures for clients
- Located conveniently in Southern California to serve clients nationwide and internationally
- Ensuring clients a headache free outsourcing experience
Providing high quality service and peace of mind for our clients differentiates us from others.
Why Choose BioPharmaDev as Your Service Partner?
- On time delivery as scheduled
- Flexibility to meet the changing needs of our clients
- Strong chromatography and analytical chemistry backgrounds
- Direct supervisions with strong technical and compliance knowledge and experience
- Exceptional technical and customer service
- Cost competitive
Access the BioPharmaDev, Inc. flyer here.
News & Events
- Nov. 19, 2018 – We would like to share with our elite clients that we received the letter from the FDA today that the inspection conducted in August 2018 was closed with a “No Action Indicated (NAI)” classification. An FDA website search result is also attached. We sincerely thank our clients for your support and for the opportunity of doing business with us.
- Aug. 23, 2018 – We are very happy to announce that today we successfully completed and passed another FDA cGMP inspection with no 483 (i.e.: 0 deficiencies). It was an inspection from the US FDA with no pre-notification. This verified our high-quality standards and status. We are very proud of this result.
- July 21, 2017 – Dr. Yan-Bo Yang co-authored an editorial article in the Journal of Molecular and Applied Bioanalysis
- Dec. 19-20, 2016 – Dr. Yan-Bo Yang gives a presentation on Analytical Characterization of Traditional Herbal Medicines at the two-day Conference on “Critical Regulatory and Compliance Issues with the US FDA in the 21st Century” in Irvine, CA.
- August 2016 – AOAC INTERNATIONAL published ALACC Guidelines – An Aid to Interpretation of ISO/IEC 17025:2005. Dr. Yan-Bo Yang was one of the key contributing leaders.
- Jul. 26, 2015 – Dr. Yang received an Official Methods Board (OMB) Award for Achievement in Technical and Scientific Excellence from AOAC
- Jul. 22, 2015 – ALACC Guidelines Revised; To Be Published August 2015
- Mar. 7, 2014 – Project Team Member for revising USP General Notice (USP 39 – NF 34)
- Dec. 23, 2013 – FDA registration renewed for 2014
- Oct. 14, 2013 – Dr. Yan-Bo Yang appointed as Chair of ALACC Dietary Supplements Subcommittee of AOAC INTERNATIONAL
- Aug. 7, 2013 – FDA registration completed
- May 15, 2012 – Chaired USP PNP Stakeholder Forum